ANTIBACTERIAL FOAMING OLIVE AND ALOE- triclosan liquid
AMERICAN SALES COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

TRICLOSAN 0.3 PERCENT

PURPOSE

ANTISEPTIC

USES

FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

APPLY ONTO WET HANDS AND WORK INTO A LATHER. RINSE THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, GLYCERETH-26, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYL BETAINE, FRAGRANCE, PROPYLENE GLYCOL, PANTHENOL, ALOE BARBADENSIS LEAF JUICE, XANTHAN GUM, BENZOPHENONE-4, IMIDAZOLIDYNL UREA, DMDM HYDANTOI N, PEG-120 METHYL GLUCOSE DIOLEATE, PEG-7 GLYCERYL COCOATE, POLYSORBATE 20, TETRASODIUM EDTA, CITRIC ACID, BLUE 1 (CI 42090), YELLOW 10 (CI 47005).

Front and back labels

ANTIBACTERIAL FOAMING OLIVE AND ALOE
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-170
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCERETH-26 (UNII: NNE56F2N14)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
SULISOBENZONE (UNII: 1W6L629B4K)
IMIDUREA (UNII: M629807ATL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-170-24	710 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/25/2011

Labeler - AMERICAN SALES COMPANY (809183973)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture